Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation.

BACKGROUND Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVES This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure. METHODS The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017. RESULTS A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio [HR]: 1.07 per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up. CONCLUSIONS Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406).

[1]  Petr Neuzil,et al.  Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). , 2013, Journal of the American College of Cardiology.

[2]  B. Meier,et al.  Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. , 2016, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[3]  A. Colombo,et al.  Left atrial appendage closure: A single center experience and comparison of two contemporary devices , 2017, Catheterization and cardiovascular interventions.

[4]  D. Tzivoni,et al.  Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion. , 2013, International journal of cardiology.

[5]  M. Price,et al.  Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. , 2014, Journal of the American College of Cardiology.

[6]  I. Cruz González,et al.  Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure , 2015, Heart.

[7]  Marco Valgimigli,et al.  Standardized Bleeding Definitions for Cardiovascular Clinical Trials: A Consensus Report From the Bleeding Academic Research Consortium , 2011, Circulation.

[8]  Saibal Kar,et al.  Safety of Percutaneous Left Atrial Appendage Closure: Results From the Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) Clinical Trial and the Continued Access Registry , 2011, Circulation.

[9]  Ulrich Schotten,et al.  2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. , 2017, Revista espanola de cardiologia.

[10]  S. Kische,et al.  Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry , 2016, European heart journal.

[11]  D. Singer,et al.  Wide Variation in Reported Rates of Stroke Across Cohorts of Patients With Atrial Fibrillation , 2017, Circulation.

[12]  J. Saw,et al.  Percutaneous left atrial appendage closure with the AMPLATZER cardiac plug device in patients with nonvalvular atrial fibrillation and contraindications to anticoagulation therapy. , 2013, Journal of the American College of Cardiology.

[13]  S. Kische,et al.  Percutaneous left atrial appendage occlusion: Device thrombosis in clopidogrel non-responders. , 2016, International journal of cardiology.

[14]  K. Chun,et al.  Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. , 2013, Heart rhythm.

[15]  P. Kirchhof,et al.  2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. , 2016, European heart journal.

[16]  J. Nielsen-Kudsk,et al.  Transcatheter left atrial appendage occlusion in patients with atrial fibrillation and a high bleeding risk using aspirin alone for post-implant antithrombotic therapy. , 2017, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[17]  J. Saw,et al.  Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug. , 2017, JACC. Cardiovascular interventions.

[18]  L. Liao,et al.  Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial). , 2016, The American journal of cardiology.

[19]  Charles E McCulloch,et al.  Relaxing the rule of ten events per variable in logistic and Cox regression. , 2007, American journal of epidemiology.

[20]  R. Virmani,et al.  Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model. , 2014, JACC. Cardiovascular interventions.

[21]  Xavier Freixa,et al.  Device‐associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet , 2017, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[22]  Saibal Kar,et al.  Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. , 2014, JAMA.

[23]  Maurice Buchbinder,et al.  Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial , 2009, The Lancet.

[24]  C. Tondo,et al.  Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry. , 2017, International journal of cardiology.

[25]  R. Erbel,et al.  Risk factors for thrombus formation on the Amplatzer Cardiac Plug after left atrial appendage occlusion. , 2013, JACC. Cardiovascular interventions.

[26]  Bernhard Meier,et al.  Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. , 2011, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[27]  G. Nickenig,et al.  Thrombus Formation After Left Atrial Appendage Occlusion With the Amplatzer Amulet Device. , 2017, JACC. Clinical electrophysiology.

[28]  Pascal Vranckx,et al.  Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. , 2012, Journal of the American College of Cardiology.

[29]  C. Macaya,et al.  Single Antiplatelet Therapy Following Left Atrial Appendage Closure in Patients With Contraindication to Anticoagulation. , 2016, Journal of the American College of Cardiology.